@Greenwave17the misconception being peddled is approvals can be secured through the FDA using real world data then evidence.
I think you'd agree thats a fairly common and generally accepted conclusion?
'but then you have the fda supporting it'....the following is the FDAs' stated guidelines on the exact subject - it is not ambiguous or open to interpretation ( though it seems a fairly regular occurrence)
the opening introduction to the FDA guidance framework for the use and implementation for real world evidence are as follows:
download (fda.gov)
For a drug already approved under section 505(c) .....or to help support or satisfy
drug post approval study requirements.
I think you'll agree there are currently
no approved schedule 3 cbd drugs/new indications available though the TGA ......nope! None.
none are able to satisfy the requirement for so called RWD/RWE because there is no appoved Sched 3 ( these must meet the requirement for trial outcomes to establish safety profile and efficacy, that 'label claim' I refer to monotonously ....before approval criteria is met.) other than GW Pharma / Epidiolex ....
the only one.....
Relevant to RWD and RWE the agency defines:
so it is easily understood that Companies who claim they can collect RWD to support RWE for a clinical trial to gain approval are dealing in 'smoke and mirrors'...
as the introduction made clear,
it is ...
For a drug already approved under section 505(c) .....or to help support or satisfy
drug post approval study requirements.
this is pretty clear - please correct me if im off the mark here on this framework / guideline to implement RWD and RWE into the process on
currently approved indications or drug post approval studies
so simply an 'initiative to pilot projects that
further the understanding of potential uses of RWD and RWE.....' for previously approved indications or again for drugs of post-approved status / studies
to each their own? nope
@Greenwave17....not a case of interpretation - its guidelines are very clear and have been since day 1.
I hope Ive helped shine a clear light on the process and framework....but probably not.
See you all on the other side - keep an eye on the market
see you all on the other side of this - good luck to everyone with the upcoming developments and news flow from this exceptional company, both management and research teams ....imo the BOD is everyting about success when investing in startups and this Incannex team really proves that philosophy.
Really enjoyed the banter and information exchange this year - learnt so much from everyone here about the market and investing that i have not seen on any other threads really - this company thread is exceptional and imo should be held dear for that exact reason.
Hope everyone has a great and merry Christmas - see you all in 2022
GLA and may the season be kind to each and every one of this community.
